A Medical Device Daily

Boston Scientific (Natick, Massachusetts) said the Japanese Ministry of Health, Labor and Welfare has approved its Acuity Steerable left ventricular lead for use with cardiac resynchronization therapy (CRT) devices to treat heart failure. The company also received reimbursement approval for the lead from the National Health Insurance System and said it plans to launch the product immediately in Japan.

The Acuity Steerable left ventricular lead features a deflectable tip for delivery in "simple, compound and complex anatomies," Boston Scientific said, which includes placement of the lead in difficult-to-access branch vessels on the left side of the heart.

"We are pleased to make this lead available to physicians in Japan so they can offer this therapy to their heart failure patients," said Fred Colen, executive VP, operations and technology, at Boston Scientific's Cardiac Rhythm Management business. "The Acuity Steerable lead, when teamed with our CRT devices, provides a proven, effective treatment option to patients who struggle with heart failure."

The Acuity Steerable lead also provides physicians with four configurations for stimulating the left side of the heart, which the company refers to as Electronic Repositioning.

"This ... allows physicians to change the stimulation site non-invasively after implant, which helps avoid the need for an additional surgical procedure," The company said. "[We are] the only company that provides physicians with four left ventricular pacing configurations."

Boston Scientific's products are used in a broad range of interventional medical specialties.

Japanese licensing deal for Corgenix

Diagnostic test kit maker Corgenix Medical (Denver) has executed a licensing agreement with the Okayama Prefecture Industrial Promotion Foundation in Japan covering new diagnostic technology for serum amyloid protein (SAP), an important serum biomarker for cardiovascular inflammation.

The technology was developed by Dr. Eiji Matsuura at the University of Okayama's Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.

Corgenix has had strategic alliances with researchers and academic institutions in Okayama since 2001. The company's AtherOx technology was developed in collaboration with researchers from the University of Okayama.

The company said this new agreement "opens additional avenues of technology and strengthens the collaboration with the Okayama Prefecture [a prefecture being the equivalent of a state] aimed at developing innovative and important diagnostic products in the future."

"We are pleased to expand our collaborative relationships in this region," said Douglass Simpson, Corgenix president/CEO. "Our alliances have already produced several exciting products, and gaining access to the SAP technology is very promising for our company.

He added: "Serum amyloid proteins are stress proteins typically elevated in bacterial and viral infections, and have been shown to be related to cardiovascular disease as well."

The agreement with Corgenix is the first one established between the Okayama Prefecture Industrial Promotion Foundation — a government agency promoting research and development among industry, universities and governments — and a U.S. company. Under the terms of the agreement, Corgenix has the exclusive rights outside of Japan to further develop the serum amyloid technology, including adapting to research and clinical diagnostic products.

Corgenix is a developer of specialized diagnostic kits for vascular diseases, immunology disorders, and bone and joint disorders. Its products are commercialized for use in clinical laboratories throughout the world. The company currently sells more than 50 products through a global distribution network.

Kyocera to rep ceramic components

Kyocera Industrial Ceramics (Vancouver, Washington) reported that it will be the North American representative of Japan Medical Materials (JMM; Osaka, Japan) for sales of biocompatible ceramic structural components used in orthopedic systems.

JMM components are immediately available from Kyocera to manufacturers of medical implant products, including total hip and total knee replacement systems. The components incorporate a wide range of biocompatible ceramics, including alumina and zirconia; bioactive coatings, such as hydroxyapatite; medical-grade alloys, such as titanium and vanadium-free titanium; and medical-grade ultra-high-molecular-weight polyethylene (UHMWPE).

Kyocera gained practical experience with U.S. regulatory processes through its preliminary marketing of biocompatible components here beginning in the 1980s. The company shifted its development efforts to Japan in the mid-1990s, where it has achieved a high level of clinical success. Building on these experiences, Kyocera believes the JMM components can support medical system manufacturers in their efforts to meet the regulatory requirements of the U.S. Food and Drug Administration.

Japan Medical Materials is a joint venture founded in 2004 by Kyocera and Kobe Steel to provide biocompatible components and systems for use in orthopedic joint replacement applications. The company is based on material synergies gained through Kyocera's extensive development of biocompatible ceramics since 1973, and Kobe Steel's development of medical-grade alloys since 1984.

Japanese subsidiary for Genetix Group

Genetix Group (New Milton, UK), a cancer diagnostic and biopharmaceutical technologies company, reported the opening of an office, Genetix KK, in Japan,

Genetix hired Eiji Takagi, to serve as president of Genetix KK, Masahiro Tateno as sales director and Katsumi Katayama as support director.

"Until now Genetix has been represented in Japan through independent distributors," said Terry Pizzie, director of global commercial operations. "Eiji, Masahiro and Katsumi have all previously held similar positions at analytical instrument firm, Biacore, which they founded and grew to be one the most successful in the Biacore family."

Genetix said its technologies "are bringing new efficiencies to biopharmaceutical and biomarker research, from target discovery through to clinical diagnosis." Its customer base includes biopharmaceutical, cytogenetic and cancer pathology groups.